Unsafe medication practices and medication errors are known to be leading causes of avoidable harm in healthcare systems worldwide. Medication errors can cause mild or severe damage, disability and even death and are estimated to cost $42 billion globally annually. The scale and nature of this harm differ between countries, with a higher impact on those patients living in low-income countries [1]. These circumstances have led to the World Health Organization’s (WHO) Third Global Patient Safety Challenge: Medication Without Harm, which aims to reduce the global level of severe, avoidable harm related to medications by 50% between 2017 and 2022.
Although medication errors could arise in all drug management processes, including prescription, preparation, dispensation, administration and monitoring, current research suggests that most medication errors occur at the administration stage [2]. Intravenously administered drugs have been associated with the highest frequencies of medication administration errors [3] and the most severe consequences for patients. Errors might arise due to the complexity of administering intravenous medication as a multi-step process involving specific administration devices, information systems and several healthcare professionals with different tasks and competencies [4]. Likewise, given their complexity and patient characteristics, current research suggests medication safety may be critical in Intensive Care Units (ICUs) [5] and, in particular, in paediatric and neonatal ICUs (PICUs and NICUs) [6], [7]. For instance, in a UK study examining 441 medication errors in hospitalised children over two years, Wilson et al. [8] found that medication errors in PICUs occurred seven times more frequently than in other paediatric inpatient units.
Several studies and systematic reviews have explored the factors contributing to medication errors. For instance, in an early and seminal study, Chapanis and Safren [9] found that the causes of medication safety incidents fell into five categories i) Non-compliance with required checking procedures, ii) Misreading or misinterpretation of written communications, iii) Transcription errors. iv) Misplaced medicine tickets at the ticket box, and v) Miscalculation errors. In a recent systematic review of the systemic causes of in-hospital intravenous medication errors, Kuitunen et al. [4] identified that insufficient actions to secure the safe use of high-alert medications, lack of knowledge of the drug, calculation tasks, failure in double-checking procedures, and confusion between look-alike, sound-alike (LA-SA) medications are leading systemic causes for medication errors affecting more than one phase of the medication process.
Medication label design is often a contributing factor to medication errors. Research has shown that one-third of reported medication incidents may be due to confusion over packaging and labelling [10]. Over the last two decades, different international reports such as the Institute of Medicine (IOM) report, To Err is Human: Building a Safer Health System [11], have suggested that drugs may be prone to error in use due to sound-alike or look-alike names, unclear labelling, or poorly designed packaging. Poor labelling design can contribute to medication errors by making it difficult for end users to identify and understand critical safety information [12]. In an integrative review, Borradale et al. [13] found that packaging and labelling design is the most commonly identified factor contributing to misreading injectable medications; the specific features named as problematic were: look-alike injectable medications, similar colours, small text, lack of colour contrast on ampules, embossed information on plastic ampules, trade name prominence, and the design of ampule/vial labels. Literature suggests that pharmaceutical companies do not consider design for safety their responsibility [14] and assume that the perfection of practitioners should eliminate medication errors [15]. As a result, several international organisations have published recommendations on the optimal design of medicines labels [12], [16], [17]. However, although those recommendations are based on human-centred design principles, minimal evidence supports their adoption [18].
Human Factors and Ergonomics (HFE) encourages the human-centred design of system elements to improve people’s well-being and system performance. It has been applied for patient safety improvement in different healthcare domains [19], [20]. Indeed, the WHO’s Global Patient Safety Action Plan 2021–2030 identified HFE as a critical strategy for building highly reliable health systems and organisations that protect patients from daily harm [21]. Recently, there has been an increasing interest in applying HFE in pharmacy to promote the human-centred design of systems to support individuals and teams performing medication-related work [22], [23]. Some scholars suggest the need to invest in healthcare HFE skills and professionals for medication safety improvement [24], integrate HFE specialists into multidisciplinary teams to improve intravenous medication safety [25], as well as embed HFE and patient safety education in pharmacy curricula [26]. Also, efforts have been made to integrate HFE in researching the design of medication labels [27].
Human error identification (HEI) methods fall within the field of HFE [28]. They could provide a valuable framework for analysing and reducing risks in healthcare [29], including medication safety. These prospective human error methods are used to identify all possible types of errors that may occur during specific tasks and suggest design solutions that can be applied in advance [30] to improve reliability and safety [31]. These methods can be used to identify or quantify errors. An example of a human error identification method is the Systematic Human Error Reduction and Prediction (SHERPA) [32], which has been used for the prospective analysis of errors in dispensing [33] and administering medicines [34].
Error quantification methods are used to determine the numerical probability of error occurrence [28]. The human error assessment and reduction technique (HEART) [35] is an HRA method that attempts to predict and quantify the likelihood of human error or failure within complex systems. Although HEART was developed within the nuclear power and chemical process industries (Stanton et al., 2005), it is intended to be applicable to different sectors [36]. Literature on patient safety highlights the advantages of transferring and applying HRA methods to healthcare services [37]. There is evidence of theoretical contributions to the use of the HEART method in healthcare (Lyons, 2004; Lyons, 2009), as well as its application in areas such as surgery [38], [39], radiotherapy [36], [40] and blood transfusion [41].
This study builds on assessing a design intervention of injectable medicine labels resulting from a programme for patient safety developed by a pharmaceutical company in Colombia [42]. After a risk analysis of medicine labels, Garnica and Aristizabal [42] identified some company products as high risk due to label design and similarity (look-alike medications, similar colours, small text, and lack of colour contrast on ampules, among others). A new labelling design was developed under the human-centred design (HCD) guidelines for safer medication provided by the Institute for Safe Medication Practices [16] and the National Patient Safety Agency [17]. Our study used a simulated scenario of a NICU to estimate the impact of the previous label design (Look-Alike LA label) versus the new label design (HCD label) on human reliability using HEART.
To the best of the authors´ knowledge, the current study is the first proactive analysis of HRA in the drug administration process and the influence of label design using HEART. Therefore, the aim of the present study is twofold: (i) to use a human reliability analysis technique to evaluate the task of medication administration within a simulated scenario of a NICU; (ii) to estimate the impact on the human reliability of a human-centred design label in medication administration compared to a label without those design characteristics. To this end, the following Research Questions are posed:
RQ1: What is the likelihood of human unreliability in a medication administration task within the simulated scenario of a NICU?
RQ2: What is the estimated impact on the human reliability of a human-centred design label in medication administration compared to a label without those design characteristics?